FDA Adverse Event Malfunction Summary report: N

ADVANTA BED

MDR report key: 4961134 · Received July 29, 2015

Report

Report Number
1824206-2015-00768
Event Type
Malfunction
Date Received
July 29, 2015
Date of Event
July 8, 2015
Report Date
July 8, 2015
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
HI, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE HILL-ROM TECHNICIAN FOUND THE POWER CONTROL BOARD FAILING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2007-2015. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CONTROL BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

HILL-ROM REC'D A REPORT FROM THE ACCOUNT STATING THE NURSE CALL WAS INOPERATIVE. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUT COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
492369 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

Patients

Seq Age Sex Outcome Treatment
1